Monthly Round-Up of What to Read on Pharma Law and Policy
Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.
Off-Label Use
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Read more: Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II) Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)
Almost immediately, there was a public outcry about the possibility that this was an illegal or unethical “research experiment.”
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Read more: Commentary: Do We Really Need a New, More Powerful Opioid? Commentary: Do We Really Need a New, More Powerful Opioid?
By Ron Litman The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx. Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In…
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Read more: Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review
Health Law Year in P/Review December 12, 2017 8:30 AM – 5:00 PM Wasserstein Hall, Milstein East AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The…
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Read more: REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review
Health Law Year in P/Review December 12, 2017 8:30 AM – 5:00 PM Wasserstein Hall, Milstein East AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The…
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Read more: REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review
Health Law Year in P/Review December 12, 2017 8:30 AM – 5:00 PM Wasserstein Hall, Milstein East AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The…
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Read more: REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review
Health Law Year in P/Review December 12, 2017 8:30 AM – 5:00 PM Wasserstein Hall, Milstein East AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The…
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Read more: How the FDA Produces Knowledge (and Is Not So Weird) How the FDA Produces Knowledge (and Is Not So Weird)
By Christopher Robertson The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA. In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech…
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Read more: Call for Papers – European Pharmaceutical Law Review (EPLR) Call for Papers – European Pharmaceutical Law Review (EPLR)
By Timo Minssen Dear Colleagues, I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here. The European Pharmaceutical Law Review (EPLR) reports on key legislative…
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Read more: Recent Developments in Off-Label Promotion Recent Developments in Off-Label Promotion
By Chris Robertson July has been a busy month for those following the controversy around off-label promotion of drugs and devices. As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses….